BIOTRONIK CardioMessenger II-S User manual

CardioMessenger®II-S
Transmitter for BIOTRONIK Home Monitoring®
Technical Manual
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BIOTRONIK mbH&o K
Woermannkehre 1
12359 Berln  ermany
Tel [phone]
Fax [phone]
BIOTRONIK, Inc
6024 SW Jean rd Bldg B
Lake Oswego, OR 97035
Phone [phone] (24-hr)
Fax [phone]
salesbotronkcom
wwwbotronkcom
©
®
by BIOTRONIK GmbH & Co. KG
All rights reserved. Specifications subject to
modification, revision and improvement.
2008-D-05
CardioMessenger is a registered trademark of
BIOTRONIK GmbH & Co. KG
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Call back light (yellow, page 14)
Operating light (yellow/green, page 13)
Use only original power supply units (page 9)
Slot for the brief instructions guide (page 12)
Connection for the power supply (page 9)
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CardioMessenger II-S 1
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 3
How Home Monitoring works . . . . . . . . . 3
Check the completeness of the delivery . . 5
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Self-test . . . . . . . . . . . . . . . . . . . . . . . . . 10
Insert brief instructions guide . . . . . . . 12
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Check lights . . . . . . . . . . . . . . . . . . . . . . 13
Call back function . . . . . . . . . . . . . . . . . 14
Switch off the system . . . . . . . . . . . . . . 15
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning, maintenance, and disposal . . . 19
Precautionary measures . . . . . . . . . . . . . 21
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . 23
Technical data . . . . . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
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2
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CardioMessenger II-S Introduction 3
Introduction
Dear patient:
You have received a pacemaker or implantable
cardioverter-defibrillator (ICD) with the
additional Home Monitoring function by
BIOTRONIK. With Home Monitoring, the state
of your heart's health and your implant are
surveyed on a daily basis while you are at
home. Your physician can catch up at regular
intervals on how your heart is doing.
How Home Monitoring works
Your implant is equipped with a special
transmitter (1). Usually at night, the
transmitter sends daily information on your
heart to the patient device, your
CardioMessenger (2).
The transmission power from your implant is
low and does not impair your health in any way.
Its limited transmission range, however,
requires the use of the CardioMessenger.
The CardioMessenger collects the information
received from the implant and automatically
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Introduction
4
transmits it to the BIOTRONIK Service Center
(4) as encoded messages via a mobile
connection (3).
Here, the messages are decoded and made
available for viewing by your physician (5) on a
protected web site.
Based on the information received, your
physician can decide if your implant is best
configured, or if the therapy needs
adjustments. In this way, Home Monitoring
serves as a practical diagnostic aid to your
physician.
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CardioMessenger II-S Check the completeness of the delivery 5
Check the completeness of the delivery
Check all components for visible damage
before using them. Use only components
which are undamaged.
The delivery includes the following:
CardioMessenger II-S
Power supply unit with electricity cable and DC
plug
Technical manual with brief instructions guide
Warning!
Use the CardioMessenger only if it is
undamaged. Return a damaged
CardioMessenger to your physician.
Warning!
Use only the original parts included (for
details, see "Technical data", page 27).
Other equipment may impair proper
functioning of the CardioMessenger and
increase the emitted interference and the
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Check the completeness of the delivery
6
device's susceptibility to interference.
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
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CardioMessenger II-S Setup 7
Setup
Place the CardioMessenger on your bedside
table. The bedside table is suitable because it
usually meets the following conditions:
2 The CardioMessenger is placed on a solid
base and cannot fall.
2 The distance to the implant is less than 2
meters so that regular data transmission at
night is assured.
At the same time is the distance to the
implant more than 20 centimeters and the
CardioMessenger has no influence on your
implant.
Warning!
The distance between CardioMessenger and
implant has to be at least 20 centimeters.
The CardioMessenger contains a mobile
module ("Mobile"). In order to prevent any
interferences of the implant, you have to
keep the prescribed minimum distance
between implant and cellular phone also to
the CardioMessenger.
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Setup
8
Please take the following also into
consideration:
2 Place the CardioMessenger in such a way
that the lights can easily be viewed during
the day. If the lights disturb you in your
sleep, turn the CardioMessenger away from
you. Do not place the CardioMessenger on
the floor, next to, or under your bed.
2 Do not place the CardioMessenger next to a
television set, microwave oven, or a similar
source of electromagnetic interference.
Note
If the CardioMessenger is too close to a
loudspeaker (or a radio alarm or TV), you
may hear interference noises typical for
cellular phones.
2 Do not expose the CardioMessenger to
temperatures exceeding 40 °C. Do not put it
on a place with direct sun light and do not
place it directly under a halogen spotlight.
2 Do not expose the CardioMessenger to
temperatures lower than 10 °C.
2 Protect the CardioMessenger against water
and high humidity. Do not place it in the
bathroom.
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CardioMessenger II-S Connection 9
Connection
Connect the CardioMessenger to the power
supply. The outlet to be used has to be easily
accessible. Use the supplied power supply unit
with electricity cable and DC plug.
Warning!
Use only the original parts included (for
details, see "Technical data", page 27).
Other equipment may impair proper
functioning of the CardioMessenger and
increase the emitted interference and the
device's susceptibility to interference.
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
1. Connect the DC plug at the end of the
electricity cable to the port on the left side
of the CardioMessenger.
The connector port is
labeled with the following
symbol:
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Connection
10
2. Connect the power supply unit to the outlet.
See that the outlet is not controlled by a
light switch. This will prevent you from
turning off the CardioMessenger
accidentally.
Self-test
The CardioMessenger automatically conducts
a self-test after being connected.
At first, both
lamps on the
front side of the
CardioMessenger
light up yellow for
a short while.
After about 10 seconds, the call back light will
turn off.
Then the
CardioMessenger checks
the connection to the
BIOTRONIK Service
Center. Only the
operating light
illuminates yellow.
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CardioMessenger II-S Connection 11
The connection check can take up to
15 minutes.
As soon as the
connection has been
checked successfully,
the operating light
illuminates green.
The CardioMessenger is now ready for use.
The CardioMessenger is intended for
continuous operation. It should be connected
at all times, especially at night.
Note
It is a sign of malfunction if the operating
light remains illuminated yellow for more
than 15 minutes or if it does not light up at
all. Details on "Debugging" can be found on
page 16.
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Connection
12
Insert brief instructions guide
Attached to the back cover of this technical
manual is a removable instructions guide.
This guide helps to inform you quickly about
the function and colors of the lights.
Additionally, you can list your physician's
phone number at the back cover of this guide.
1. Remove the guide from this technical
manual.
2. Write your physician's or the clinic's name
and phone number on the back cover of this
guide.
3. Insert the brief instructions guide into the
slot on the left side into the housing of the
CardioMessenger.
Now the brief instructions guide with your
physician's phone number are ready at hand.
Use it if the call back function of the
CardioMessenger was activated by your
physician. Details on "Call back function" can
be found on page 14.
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CardioMessenger II-S Operate 13
Operate
The CardioMessenger
does not have an on/off
switch. After connecting it,
it is ready for use as soon
as the operating light
illuminates green.
It is intended for continuous operation and
should remain connected at all times,
especially at night.
The CardioMessenger automatically receives
the information from your implant and
transmits it to the BIOTRONIK Service Center.
Note
It indicates a malfunction if the operating
light illuminates yellow or does not light up
at all. Details on "Debugging" can be found
on page 16.
Check lights
Check once a day whether either of the two
lights is illuminated.
Usually the operating
light illuminates green.
The call back light is
not illuminated.
Note
The functions of your implant are not
affected at any time by the
CardioMessenger, irrespective of the
illumination or blinking of the lights.
See the next page for details on the subject
"Call back function".
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Operate
14
Call back function
With the aid of the call back light, your
physician can ask you to call him. Via mobile
network, he can turn the light on. The light will
then blink yellow for a maximum time of 3
days.
The call back light blinks
if your physician expects
your call.
Your physician will let you know whether he or
she intends to use this function in general.
Perform call back
Call your physician as soon as you realize that
the call back light is blinking.
Note
The brief instructions guide with your
physician's phone number is located in the
housing of the CardioMessenger (see
"Insert brief instructions guide", page 12).
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CardioMessenger II-S Operate 15
Turn off the call back light
To turn off the call back light, disconnect the
CardioMessenger briefly from the main supply.
1. Pull the DC plug at the end of the electricity
cable out of the port on the left side of the
CardioMessenger.
Both lights will turn off.
2. Connect the DC plug to the port again.
The CardioMessenger performs the self-test.
Afterwards, the operating light will illuminate
green and the call back light will no longer be
blinking.
Note
Details on "Connection" can be found on
page 9.
Switch off the system
The CardioMessenger does not have an on/off
switch. To turn off the CardioMessenger,
disconnect it from the main supply.
1. Remove the power plug from the wall
outlet.
The operating control lamp will turn out. The
CardioMessenger is switched off.
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Debugging
16
Debugging
You can identify issues with your CardioMessenger by use of the lights on the front side.
Light Behavior Operating status
Call back
light Off Normal operation;
no malfunction
Yellow blinking Your attending physician is asking for a call (Details on
"Call back function" can be found on page 14.);
no malfunction
Yellow blinking Error type B (both lights blink yellow): Repeat the self-
test, see next page for further details
Operating
light Off Error type A: Check the power supply, see next page
Green illumination The CardioMessenger is now ready for use;
no malfunction
Yellow blinking Error type B (both lights blink yellow): Repeat the self-
test, see next page for further details
Yellow illumination Error type C (only this light illuminates): Check the
mobile connection, see next page
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CardioMessenger II-S Debugging 17
Error type A
Check the power supply
The operating light is off. CardioMessenger is
not ready for use.
Check the power supply:
2 Make sure that the DC plug of the electrical
cord is plugged in tightly into the port on the
left side of the CardioMessenger.
2 Make sure that the power supply unit is
inserted properly into the wall outlet.
2 Make sure that the outlet has current, for
example by temporarily connecting the
bedside lamp to the outlet and by turning
the lamp on.
If you do not find any errors, contact your
physician.
Error type B
Repeat the self-test
Both lights blink yellow. The CardioMessenger
has not concluded the self-test. It is not yet
ready for use.
1. Remove the power supply unit from the wall
outlet.
2. Reconnect it.
The CardioMessenger restarts and performs
the self-test. Both lights will illuminate yellow.
The call back light will turn off once the self-
test is complete. The operating light will
remain illuminated yellow. Next, the
CardioMessenger checks the connection to the
BIOTRONIK Service Center. The operating
light switches to green once the connection
test is sucessful. The CardioMessenger is now
ready for use.
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